Ensuring Safe and Effective Pharmaceutical Products: A Comprehensive Guide to ICH Q9 (R1) Quality Risk Management in the Pharmaceutical Industry
Learn the principles and process of ICH Q9(R1) quality risk management and how to apply it in manufacturing, drug development and post-marketing activities.
Speaker
Meredith Crabtree
Quality consultant · 25+ years in regulated industries
Overview
ICH Q9 sets out a systematic, proactive way to manage risks to product quality, patient safety and data integrity, with risk management built into the pharmaceutical quality system across the product life cycle. This 90-minute ICH Q9(R1) quality risk management training focuses on the revised guideline.
You'll learn about the International Council for Harmonisation and the purpose of Q9(R1), then work through key concepts: risk, risk management and the principles of quality risk management. The session follows the five steps of the process, from risk identification and evaluation to control, communication and review.
You'll also see how risk management applies in pharmaceutical manufacturing, drug development and post-marketing activities, along with common QRM methods, tools and example applications.
Why attend: Applying quality risk management well supports regulatory compliance, stronger quality systems, better decisions, cross-functional collaboration and continuous improvement. This session gives you a foundation in ICH Q9(R1) that you can use in your own role to improve product quality and patient safety. It suits QA/QC, manufacturing and operations, R&D, regulatory affairs, pharmacovigilance and drug safety, and risk management professionals, plus project managers and cross-functional team members.
What’s covered
- A brief overview of ICH and its purpose
- Introduction to ICH Q9 and why it matters
- Understanding risk and risk management
- Principles of quality risk management
- Risk assessment, control, communication and review
- Risk identification
- Risk evaluation
- Risk control
- Risk communication
- Risk review
- Applying ICH Q9 in pharmaceutical manufacturing
- Risk management in drug development
- Risk management in post-marketing activities
- Overview of QRM methods and tools
- Potential applications of quality risk management
Who should attend
What you get
About the speaker
Meredith Crabtree has over 25 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical devices, Cosmetics, Supplements, and Animal Health manufacturing and distribution. Meredith works as a Quality Consultant performing label reviews, 3rd party inspections, Consent Decree, and Recall support. She also performs regulatory assessments and Quality training. Meredith has a degree in Medical Technology and is currently obtaining a degree in Quality Systems.
More in FDA Compliance
See all 46 FDA webinars →
Carolyn Troiano · 90 min
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11 Compliance
David Nettleton · 75 min
Major cGMP Issues: FDA Concerns in 2026
Ms. Michael Redmond · 60 min
Performance of Root Cause Analysis, CAPA, and Effectiveness Checks
Meredith Crabtree · 90 min